MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUN REV OFFST STM ADPTR 4MM; KNEE STEMS

Model Number	1513-04-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	04/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Clinical adverse event received for pain and giving way of study knee while walking longer distances.Event is not serious and is considered mild.There is a remote possibility that the event is related to both device and procedure.Date of implantation: (b)(6) 2018, date of event (onset): (b)(6) 2019, (right knee).Treatment: invasive knee aspiration and physical therapy.
Additional Manufacturer Narrative
Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: corrected: e1 (country code).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.
Event or Problem Description
Clinical notification attachment reviewed and indicates "giving ways of study knee while longer walking distances because of pain, no instability".
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.Removed patient harm joint instability as per additonal clinical notification received.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ATTUN REV OFFST STM ADPTR 4MM
• Common Device Name: KNEE STEMS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10299970
• Report Number: 1818910-2020-16293
• Device Sequence Number: 485218
• Product Code: JWH
• UDI-Device Identifier: 10603295475132
• UDI-Public: 10603295475132
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K160700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1513-04-000
• Device Catalogue Number: 151304000
• Device Lot Number: 8609885
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 07/24/2020; 08/12/2020; 09/10/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 07/29/2020; 08/17/2020; 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUN REV OFFST STM ADPTR 4MM; ATTUNE CEMENTED STEM 14X30MM; ATTUNE CRS FB INSRT SZ 4 16MM; ATTUNE CRS FEMORAL RT SZ 4 CEM; ATTUNE DIST FEM AUG SZ 4 4MM; ATTUNE DIST FEM AUG SZ 4 4MM; ATUNE CRS FB TIB BASE SZ 4 CEM; ATUNE PRESSFIT STR STEM16X60MM; COMPETITOR BONE CEMENT; ATTUN REV OFFST STM ADPTR 4 MM; ATTUNE CEMENTED STEM 14X30 MM; ATTUNE CRS FB INSRT SZ 4 16 MM; ATTUNE CRS FEMORAL RT SZ 4 CEM; ATTUNE DIST FEM AUG SZ 4 4 MM; ATTUNE DIST FEM AUG SZ 4 4 MM; ATUNE CRS FB TIB BASE SZ 4 CEM; ATUNE PRESSFIT STR STEM16X60 MM; COMPETITOR BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 72